NECC sterile rooms were infected

Oct. 27, 2012

Written by

Tom Wilemon and Walter F. Roche Jr.

The Tennessean

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The contaminated medicine blamed for 10 fungal meningitis deaths in Tennessee started out in a pharmacy where mold and bacteria grew in “clean rooms,” a leaking boiler left puddles on the floor, and equipment was soiled with greenish-yellow residue, an inspection report released Friday shows.

The New England Compounding Center detected mold in its production areas since January through its own monitoring program but apparently did nothing about it, the U.S. Food and Drug Administration report said.

Fungal infections linked to the pharmacy’s tainted medicine have sickened 338 people nationwide, with 74 of those cases in Tennessee. The Tennessee Department of Health reported one more death Friday and four new illnesses. But 18 of the people sickened with meningitis in Tennessee have been able to return home from the hospital after being treated with antifungal medications.

The outbreak has passed its peak in Tennessee, according to Health Commissioner John Dreyzehner, who said he expects illnesses to ebb by Nov. 8 — six weeks after the last use of the contaminated medicines in steroid epidurals.

'An incubator' of mold

“The entire pharmacy was an incubator of bacteria and fungus,” said Sarah Sellers, a former FDA officer who left the agency in 2008 after unsuccessfully pushing it to increase regulation of compounding pharmacies. She now consults for drug manufacturers.

“The pharmacy knew this through monitoring results and chose to do nothing.”

The descriptions in the report are from inspections of the compounding lab on Oct. 2, 4, 5, 9, 15 and 26.

New England Compounding responded with a prepared statement: “We will review this report and will continue our cooperation with the FDA. We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report.”

The Framingham, Mass.-based compounding pharmacy has closed, recalled all of its products and become the subject of a federal criminal investigation.

Public Citizen, a nonprofit organization that advocates for public safety, said the inspections should have occurred much sooner and rejected claims by FDA officials that the agency did not have authority to do them. It called for an independent investigation.

“Given the attempts to dodge responsibility in this matter, the FDA is clearly incapable of conducting an objective evaluation of its own policy, oversight and enforcement decisions, which no doubt contributed to this ongoing preventable tragedy,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.

“An independent investigation must be conducted and should identify all agency officials whose actions and decisions contributed to the FDA’s failure to prevent this public health catastrophe.”

Rooms infected

Before ever putting methylprednisolone acetate from New England Compounding under a microscope earlier this month, FDA inspectors could see “greenish black foreign matter” and “white filamentous material” floating around in the vials.

The FDA said it found bacteria and mold in two of the lab’s clean rooms, areas for the production of sterile drugs. Clean rooms are specially designed to have low levels of contamination and keep out dust, airborne microbes and other particles. One way this is done is to filter air through air conditioning and filtering.

Staff reported to FDA that the firm shut off the air conditioning in the clean room every night from 8 p.m. to 5:30 a.m.

Inspectors also noted failures in labeling and documentation needed to distinguish raw and nonsterile active pharmaceutical ingredients from sterile ones.

They found yellow and tarnished discoloration on equipment used in the sterilization process. They also found “yellow residue” and “green residue” lining hoods of equipment used to weigh active ingredients and raw materials used to make medicines.

Foreign substances were found on heating and cooling vent louvers behind a piece of equipment used to make bulk drug suspensions of preservative-free methylprednisolone and triamcinolone.

“A boiler installed within approximately 30 feet of the entrance to the Prep Room (ISO 8) was observed to be leaking water into puddles,” the report states. “Moreover, wet floor surfaces around the boiler appeared to be soiled with thick white debris and thick black, granular material.

“Gaps were observed between sliding doors, located in the transition between the Prep Room (ISO 8) and the warehouse, despite being fully closed. This room is used for the preparation of equipment.”

No investigation

The company’s own environmental monitoring program found bacteria and mold in two of its clean rooms at least 79 times between January and September, the FDA said. This included areas where sterile gowns, booties and other clothing were kept and a bin that held tamper-evidence caps.

The results were not investigated, and the firm did not identify the bacteria or molds found growing in its clean rooms, the FDA report said. No product-impact assessments were done for any of the sterile products made on the days the samples were taken.

“In addition, the firm has no evidence that any corrective actions were taken to prevent contamination of the sterile drug products,” the FDA report said.

New lawsuits filed

The FDA report provides valuable evidence for lawyers suing the Massachusetts company. Two new lawsuits were filed Friday in Nashville.

In the first, Shirley Higdon and her husband, Henry, of Decatur County are seeking $15 million in damages from New England Compounding for injuries she suffered after treatment with a drug provided by the firm.

According to the seven-page complaint, Shirley Higdon was injected with the steroid methylprednisolone from NECC on Sept. 10 at Saint Thomas Outpatient Neurosurgery Center and later was diagnosed with fungal meningitis.

As a result, the suit states, Shirley Higdon “has suffered horribly and been terribly injured.”

In the second suit, also against New England Compounding, lawyers for John Jay Slatton of Smith County charged that he contracted meningitis after being injected on Aug. 8 and Aug. 23 at Saint Thomas.

Charging that Slatton was injected with fungus-tainted steroids, the suit seeks $10 million in damages for him and his wife, Leann.

Contact Tom Wilemon at 615-726-5961 or twilemon@tennessean.com or follow him on Twitter @TomWilemon. Contact Walter F. Roche at 615-259-8086 or wroche@tennessean.com. USA TODAY and The Associated Press contributed to this report.